Trial Outcomes & Findings for Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity (NCT NCT01494649)
NCT ID: NCT01494649
Last Updated: 2013-05-08
Results Overview
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.
COMPLETED
NA
118 participants
Baseline and immediately after treatment administration
2013-05-08
Participant Flow
Participants were recruited at the clinical site
Participant milestones
| Measure |
Test
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
|
Negative Control
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
|
Overall Study
COMPLETED
|
59
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Test
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
|
Negative Control
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
Test
n=59 Participants
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
|
Negative Control
n=59 Participants
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
35.7 Years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
37.0 Years
STANDARD_DEVIATION 9.98 • n=7 Participants
|
36.3 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
USA
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and immediately after treatment administrationPopulation: Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.
Outcome measures
| Measure |
Test
n=59 Participants
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
|
Negative Control
n=59 Participants
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment
|
-0.42 units on a scale
Interval -0.53 to -0.3
|
-0.32 units on a scale
Interval -0.43 to -0.21
|
SECONDARY outcome
Timeframe: Baseline and Day 3Population: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.
Outcome measures
| Measure |
Test
n=59 Participants
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
|
Negative Control
n=58 Participants
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3
|
-0.57 units on a scale
95% Confidence Interval 0.515 • Interval -0.69 to -0.44
|
-0.45 units on a scale
95% Confidence Interval 0.478 • Interval -0.57 to -0.32
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.
Outcome measures
| Measure |
Test
n=59 Participants
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
|
Negative Control
n=58 Participants
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14
|
-1.24 units on a scale
95% Confidence Interval 0.604 • Interval -1.39 to -1.08
|
-0.72 units on a scale
95% Confidence Interval 0.622 • Interval -0.87 to -0.56
|
SECONDARY outcome
Timeframe: Baseline and immediately after treatment administrationPopulation: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.
Outcome measures
| Measure |
Test
n=59 Participants
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
|
Negative Control
n=59 Participants
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment
|
3.73 units on a scale
95% Confidence Interval 5.539 • Interval 2.03 to 5.43
|
3.81 units on a scale
95% Confidence Interval 7.505 • Interval 2.11 to 5.51
|
SECONDARY outcome
Timeframe: Baseline and Day 3Population: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.
Outcome measures
| Measure |
Test
n=59 Participants
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
|
Negative Control
n=58 Participants
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3
|
4.83 units on a scale
95% Confidence Interval 7.190 • Interval 2.49 to 7.17
|
6.90 units on a scale
95% Confidence Interval 10.630 • Interval 4.54 to 9.25
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.
Outcome measures
| Measure |
Test
n=59 Participants
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
|
Negative Control
n=58 Participants
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14
|
15.85 units on a scale
95% Confidence Interval 12.600 • Interval 12.51 to 19.18
|
7.16 units on a scale
95% Confidence Interval 13.249 • Interval 3.79 to 10.52
|
Adverse Events
Test
Negative Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER